A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
DURGA-4
A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.
2 other identifiers
interventional
508
14 countries
111
Brief Summary
This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2026
Typical duration for phase_3
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
February 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 12, 2030
April 30, 2026
April 1, 2026
2.3 years
January 30, 2026
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.
PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.
3 years
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM.
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
2 years
Secondary Outcomes (3)
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.
2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.
2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.
5 years
Study Arms (2)
Arm A
EXPERIMENTALAZD0120
Arm B
ACTIVE COMPARATOR1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
- Documented evidence of measurable disease:
- Serum M-protein level ≥ 1 g/dL
- Urine M-protein level ≥ 200 mg/24h
- Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy
- Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy
- Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
- ECOG performance status score of 0 to 1
- Adequate hematology and chemistry laboratory values:
- Haemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3)
- Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with \< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells
- Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
- +1 more criteria
You may not qualify if:
- Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
- Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
- Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
- Significant neurological or psychiatric condition
- Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
- Previously received any prior BCMA-targeted treatment
- Previously received CAR-T or CAR-NK therapy directed at any target
- Previously received T-cell engager therapy directed at any target
- Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (111)
Research Site
Gilbert, Arizona, 85234, United States
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Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85719, United States
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La Jolla, California, 92093, United States
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Sacramento, California, 95817, United States
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Santa Monica, California, 90404, United States
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Denver, Colorado, 80218, United States
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New Haven, Connecticut, 06510, United States
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Washington D.C., District of Columbia, 20007, United States
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Coral Gables, Florida, 33156, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60612, United States
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Park Ridge, Illinois, 60068, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40207, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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New York, New York, 10016, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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Rochester, New York, 14642, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27514, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45220, United States
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Cleveland, Ohio, 44195, United States
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Portland, Oregon, 97239, United States
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Charleston, South Carolina, 29425, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78704, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84112, United States
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Charlottesville, Virginia, 22908, United States
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Richmond, Virginia, 23298, United States
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Seattle, Washington, 98104, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53226, United States
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Camperdown, 2050, Australia
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Darlinghurst, 2010, Australia
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Fitzroy, VIC3065, Australia
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Liverpool, 2170, Australia
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Melbourne, 3000, Australia
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Melbourne, 3004, Australia
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Murdoch, WA6150, Australia
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Salvador, 41253-190, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 05652-900, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Lille, 59037, France
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Nantes, 44093, France
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Paris, 75010, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Toulouse, 31059, France
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Berlin, 12200, Germany
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Leipzig, 04103, Germany
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Mainz, 55131, Germany
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Nuremberg, 90419, Germany
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Würzburg, 97080, Germany
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Bologna, 40138, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Rozzano, 20089, Italy
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Torino, 10126, Italy
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Bunkyō City, 113-8431, Japan
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Kashiwa, 277-8577, Japan
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Kyoto, 602-8566, Japan
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Nagoya, 467-8602, Japan
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Shibuya-ku, 150-8935, Japan
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Shinjuku-ku, 160-8582, Japan
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Oslo, 0450, Norway
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Gdansk, 80-952, Poland
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Gliwice, 44-101, Poland
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Lublin, 20-090, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-776, Poland
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Wroclaw, 50-367, Poland
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 5505, South Korea
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Madrid, 28041, Spain
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Pamplona, 31008, Spain
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Salamanca, 37007, Spain
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Santander, 39008, Spain
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Valencia, 46026, Spain
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Taipei, 10002, Taiwan
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Taipei, 106, Taiwan
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Taipei, 112, Taiwan
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Birmingham, B9 5SS, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Glasgow, Scotland, G12 0YN, United Kingdom
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London, SM2 5NG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2026
First Posted
February 6, 2026
Study Start
February 23, 2026
Primary Completion (Estimated)
June 14, 2028
Study Completion (Estimated)
August 12, 2030
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.